NIMESIL Grant. 100 mg. 15 granule
NIMESIL Grant. 100 mg. 15 granule
What is in your medicine?
One sachet with 2 g granules for oral suspension (for oral administration) contain:
100 mg nimesulide
Sucrose, orange flavor, citric acid, maltodextrin, tsetomakrogol.
Nimesil is 9.15 or packs of 30 sachets.
How does Nimesil?
Nimesil is medicine of the nonsteroidal anti-inflammatory drugs (NSAIDs).
When applied Nimesil?
Treatment of acute pain.
Symptomatic treatment of painful osteoarthritis.
When you need to apply Nimesil?
When a known hypersensitivity to nimesulide or to any of the excipients;
evidence of hypersensitivity reactions (eg bronchospasm, rhinitis, hives) after administration of aspirin or other NSAIDs;
evidence of liver injury following administration of nimesulide;
ulcer of the stomach or duodenum, data recurrent ulcers or bleeding from the gastrointestinal tract (two or more distinct episodes of proven ulceration or bleeding), including those caused by NSAID use, cerebrovascular hemorrhage, other active bleeding or bleeding disorders;
severe bleeding disorders;
severe heart failure
severe renal impairment;
Children under 12 years of age;
the last three months of pregnancy or during lactation.
What you should know before you start treatment with Nimesil?
The risk of side effects may be reduced if Nimezil apply to the lowest effective dose in the shortest possible time. In the absence of effect, treatment should be discontinued.
If during treatment with Nimezil develops symptoms similar to those of liver damage (eg, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) or appear abnormal liver function, treatment should be discontinued. In these cases should not be treated again with nimesulide. After administration of the drug has been reported liver damage, which in most cases is reversible.
Concomitant administration of drugs that damage the liver, and alcohol should be avoided during treatment with Nimezil, as this may increase the risk of liver reactions.
During treatment Nimezil should not take other analgesics. Concomitant use of other NSAIDs.
Bleeding from the gastrointestinal tract or ulcer / perforation can occur at any time during treatment, with or without warning symptoms. The same can be observed for evidence of similar prior gastrointestinal disorders. In the gastro-intestinal tract or ulcer, administration of nimesulide should be discontinued. Nimesulide should be used with caution in patients with gastrointestinal disorders, including the data for peptic ulcers or signs of bleeding from the gastrointestinal tract, ulcerative colitis or Crohn's disease.
Caution is recommended in patients with renal impairment or heart complaints as the use of nimesulide may cause renal dysfunction. In case of deterioration, treatment should be discontinued.
Elderly patients are particularly susceptible to the adverse effects of NSAIDs, including bleeding or perforation of the gastrointestinal, renal, cardiac or hepatic function. It is therefore recommended that adequate clinical monitoring.
Since it is possible nimesulide affect platelet function should be used with caution in patients with bleeding tendency. Nimesulide can be used instead of aspirin for cardiovascular prophylaxis.
NSAIDs may mask fever due to a bacterial infection of the subject.
Caution should be exercised in patients with a history of hypertension or heart failure because of the risk of fluid retention and swelling.
Very rarely in association with the use of NSAIDs, severe skin reactions. These effects occur in the majority of cases within the first month of treatment. Discontinue at the first skin symptoms.
What interactions occur between Nimesil other medicines you are taking?
Patients using drugs that inhibit blood clotting, are at increased risk of bleeding during treatment with nimesulide. If the combination can not be avoided, Anticoagulant activity should be monitored carefully. Nimesulide may reduce the effects of certain medications that increase urine output (furosemide).
Co-administration of lithium and NSAIDs increases the serum lithium levels and therefore may increase the side effects. Prescribe nimesulide If a patient is being treated with lithium, lithium levels should be carefully monitored.
Nimesulide may increase the side effects of methotrexate. Therefore, nimesulide should be used with caution, not less than 24 hours before or after administration of methotrexate.
Nimesulide may potentiate the effects of cyclosporine on the kidney.
Can be used Nimesil during pregnancy and lactation?
Nimezil should not apply in the last three months of pregnancy and during lactation.
The use of nimesulide may impair fertility in women and is not recommended for women who are trying to conceive, who had problems conceiving or who are carrying out research into infertility.
3 Alters Nimesil you the ability to drive and use machines?
If after taking Nimesil experience dizziness, vertigo or drowsiness, do not drive or operate machinery.
How and how much time should be given Nimezil?
Nimesil should be used depending on the clinical situation in the shortest possible time.
Nimesil should not be used in children under 12 years of age.
Adults and adolescents 12 to 18 years
At one sachet (100 mg nimesulide) twice daily after meals. Elderly
There is no need for dose reduction in the elderly. Impaired renal function
In patients with mild to moderate renal impairment (creatinine clearance 30-80 ml / min) no dose adjustment. Nimezil should not be used in patients with severe renal impairment (creatinine clearance <30 ml / min).
Nimezil should not be administered to patients with hepatic impairment. The contents of one sachet (100 mg nimesulide) dissolved in a glass of water.
What should I do in case of overdose Nimesil!
Symptoms following acute NSAID overdoses are usually limited to fatigue, dizziness, nausea, vomiting and abdominal pain, which are generally reversible with supportive care administered. Can manifest bleeding from the gastrointestinal tract. Rarely observed hypertension, acute renal failure, respiratory depression and coma. In the administration of therapeutic doses of NSAIDs, and an overdose can occur anaphylactic (allergic) reactions.
After overdosage with NSAIDs should be given symptomatic and supportive treatment. There is no specific antidote. It can cause vomiting and / or apply charcoal (60 to 100 g in adults) and / or osmotic laxatives in patients with up to 4 hours after administration of an overdose or at high doses. Forced diuresis (causing release of large amounts of urine), alkalinization of urine, hemodialysis, or hemoperfusion may not be effective due to high protein binding. You should monitor renal and hepatic function.
In case of taking higher than recommended dose, please, consult your doctor!
What side effects can cause Nimesil?
These side effects are based on controlled clinical trials * (in about 7800 patients) and subsequent observations by Frequencies are classified as very common (> 1/10), common (> 1/100, <1/10) Uncommon (> 1/1000, <1/100), rare (> 1/10000, <1/1000), very rare (<1/10000), including isolated reports.
Side of blood disorders
Rare Decreased erythrocytes or hemoglobin (anemia) *
Increased number of eosinophils (eosinophilia) *
Decreased platelet count (thrombocytopenia)
Decreased number of blood cells (pancytopenia)
Bleeding under skin and mucous membranes (purpura)
Very rare Anaphylaxis (renal) reaction
Metabolism and nutrition
Rare Elevated potassium levels in the blood
Rare Anxiety Nervousness
Very rare Drowsiness Headache encephalopathy (brain damage syndrome Ray)
Disorders of the Eye
Rare Blurred vision
Eye disorders Very rare
Disorders of the Ear and labyrinth
Very rare Vertigo
Rare Fast heart rate
Nechesgi Increased blood pressure
Rare Bleeding Fluctuating blood pressure Hot flushes
Nechesgi Breathlessness *
Very rare Asthma bronchial spasm
Frequent Diarrhea Nausea Vomiting
Nechesgi constipation Bloating gas (flatulence) * Gastritis
Very rare Abdominal pain Indigestion Inflammation of the mouth (stomatitis) Katranenocherni feces due to bleeding from the gastrointestinal tract (melena) Bleeding from gastrointestinal ulceration and perforation of duodenal ulcer and gastric perforation
Hepatobiliary disorders (see "What you should know before you start treatment with Nimezil?")
Very rare lightning Hepatitis hepatitis (including fatal) Jaundice stagnation of bile
Disorders of the side skin and the subcutis
Itchy Rash Nechesgi * Increased sweating
Rare Flushing Dermatitis
Very rare Hives (urticaria) Angioedema (swelling of the face, neck, larynx) Facial edema Erythema multiforme (mnogoformeno redness) Stevens-Johnson syndrome (skin rash with blistering) Toxic epidermal necrolysis (localized damage to the upper binder the skin)
Disorders of the urinary tract
Rare Pain with urination blood in urine Urinary retention
Very rare renal failure Decreased urine output Interstitial nephritis (kidney inflammation)
Rare Weakness Fatigue
Very rare low temperature
Common Elevation of liver enzymes
In the event of any adverse reaction which is not described in the table or in poor general condition, tell your doctor immediately!
How to store Nimesil?
Protect from light, moisture and heat! Keep out of reach of children!
Do not use after the expiry date printed on the package!